Submission Procedure – Abridged Assessment of an APIMF Previously Approved by an Authority Applying Stringent Standards
1. eCTD submissions
The preferred format for APIMF applications submitted to PQT is in eCTD format.
Information on documents expected in an eCTD formatted APIMF application, and other guidance related to eCTD can be located on the dedicated eCTD webpage
2. Non-eCTD submissions
API prequalification applications may still be submitted in non-eCTD format until approximately May 2026.
3. Documents to be submitted
Submission of an application for abridged assessment of an active pharmaceutical ingredient master file (APIMF), previously approved by an authority applying stringent standards for API prequalification, involves preparation and submission of a number of documents in electronic format, as follows:
| Cover letter | Mandatory |
| Application Form | Mandatory |
| Manufacturing Authorisations/Registrations/CPPs | Optional |
| Copy of certificate(s) of suitability of the European Pharmacopoeia (CEP) (including any annexes) | Optional |
| Letters of access for active pharmaceutical ingredient master files (APIMFs) | Optional |
| Good manufacturing practices (GMP) information | Optional |
| Summary of Changes document | Optional |
| Previous Commitments | Optional |
| NRA approval | Optional |
The NRA approval documents should include:
- a copy of the letter to EDQM or US FDA authorizing sharing of the APIMF assessment report with WHO
- a chronological summary of the assessments that were undertaken by the Agency during the initial approval or when changes were made, following approval, summary of any changes made over time to the details of the APIMF submitted to the Agency
- If applicable, a summary of the differences between the details of the APIMF submitted to WHO and those of the APIMF currently accepted by the Agency
Please note that minor differences between the details currently held by the authority and those that are being submitted to WHO are permissible.
Following receipt of the application, WHO will contact the authority and request that it provide access to its assessment report.
The applicant may provide information additional to that outlined above, provided it is clear and well summarized.
4. Where to send an application for product evaluation of an API and responses to requests for further information
Applications and subsequent responses to questions should be created and submitted via the ePQS Portal.
Further information on the ePQS Portal, including how to make submissions are available at the Portal